Kornimate/medical-research-clean huggingface dataset:
first level socio-geriatric evaluation: esoger databank

Conditions: COVID; Social Isolation; Anxiety; Frailty

Summary: coronavirus disease 2019 (covid-19) is an infectious disease. physical distancing is one of the most effective ways to reduce the spread of covid-19, but this key prevention intervention may have adverse consequences on older adults living at home. screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. esoger ("evaluation social et geriatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to covid-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. experience cumulated during the past two weeks revealed that esoger could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to covid-19 physical distancing. this improvement is based on two key components: 1) comments of montreal esoger users and 2) analysis of data. because at this time no information is saved and stored, there is a need to save and store esoger information and create the esoger databank.


Eligibility criteria:
the inclusion criteria are: 1. older (i.e., 70-years-old and over) adults or caregiver living at home with an adult answering to inclusion criteria 2. living and staying at home because of physical and social distancing 3. understanding and writing the different languages of the recruitment centre (i.e., french, english, chinese.) 4. agree to participate in the study the exclusion criteria are: 1. a concomitant participation to another medical trial 2. living in semi-autonomous residence or chsld
immunological consequences of card15/nod2 mutations in crohn's disease

Conditions: Crohn's Disease

Summary: the project is based on adult and paediatric cohorts among the largest ones in paris and located at saint louis and robert debré hospitals. experiments will be performed at inserm unit u843 in collaboration with the department of immunology and statistics, robert debré hospital.

crohn's disease (cd) affects about 60.000 to 80.000 people in france. it is characterised by a chronic or relapsing inflammation of the gut. its aetiology is largely unknown, limiting the development of preventive and curative therapeutic options. in 2001, we have identified the first cd susceptibility gene: card15/nod2. this gene is involved in the innate immune response but we do not know today how gene mutations may induce the disease lesions. however, many data suggest that the intestinal inflammation may be related with an abnormal function of the lymphoid tissue present in the gut. the aim of the present proposal is to better understand the role of card15/nod2 mutations (r702w, g908r and 1007fs) in the development and the function of the intestinal lymphoid tissue. 250 patients and controls will be enrolled at robert debré and saint louis hospital (paris, france) within a 2 years period. for participant, 4 to 5 ileal biopsies will be taken during a routine colonoscopy. patients will be classed in three groups according to their number of card15/nod2 mutations (1) wild-type, 2) mutated heterozygotes and 3) mutated homozygotes or compound heterozygotes). a comparison between groups and with non inflammatory (colonoscopy performed for other reasons) or inflammatory (ulcerative colitis patients) controls will be done. for each group, cell phenotype, cytokine profile, permeability and bacterial translocation will be analysed on peyer's patches. the project is based on adult and paediatric cohorts among the largest ones in paris and located at saint louis and robert debré hospitals. experiments will be performed at inserm unit u843 in collaboration with the department of immunology and statistics, robert debré hospital.

Eligibility criteria:
inclusion criteria: * children and adults ≥ 5 ans and ≤ 65 ans with a programmed routine colonoscopy for crohn's disease, ulcerative colitis, or another benign gastroenterological disorder exclusion criteria: * patients \ 65 ans * patients with contra-indications for multiple biopsies * patients with an undeterminate colitis

Keywords: crohn's disease, inflammatory bowel disease, peyer's patches
evaluation of a speech-to-noise feedback device for treatment of hypophonia in parkinson's disease

Conditions: Parkinson Disease

Summary: this study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in parkinson's disease. the procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. the device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

this study will evaluate the effectiveness of a speech-to-noise feedback procedure for the treatment of hypophonia in parkinson's disease. the procedure includes a device that records the sound intensity level of the wearer's speech and compares it to the noise level around them. the device will provide the wearer with feedback if their speech becomes too quiet for them to be heard by their listener.

Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease and hypophonia by a neurologist at least 6 months prior to participation. * stabilized on antiparkinsonian medication. * good general health. * pass a 40 decibel hearing screening. * proficient enough in english to participate in speech testing. exclusion criteria: * history of stroke or an additional neurological or motor control disorder. * history of speech impairment that is unrelated to parkinson's disease.
a study of thymidylate synthase expression in patients with non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: thymidylate synthase (ts) is a substance the body produces naturally. the purpose of this research is to determine if there is a link between ts production and how well patients respond to treatment of non-squamous non-small cell lung cancer (nsclc). the aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much ts they produce.

all patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). in general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment. ts levels will be measured from the tumour sample used to make the original diagnosis of nsclc.

Eligibility criteria:
inclusion criteria: * patients must have stage 3b or 4 non-small cell lung cancer of the non- squamous type * patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work * patients must not have had previous chemotherapy treatment for lung cancer * patients must not have had radiotherapy in the last 30 days * patients must have measureable tumor lesions according to the response evaluation criteria in solid tumors (recist) guidelines or disease that can be evaluated on computed tomography (ct) scan * patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory * women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception exclusion criteria: * patients cannot have received other investigational drugs within the last 30 days * patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely * patients cannot have a current second primary malignant tumor * patients cannot be having current treatment with any other anti-tumor therapy * patients cannot have had a yellow fever vaccination within 30 days of enrolment * patients who are unable to take vitamins (including injections of vitamin b12) or oral cortisone medication * patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents * patients who are pregnant or breastfeeding
comparison of the safety and efficacy of ophtesis bio 3% with a similar 3% sodium hyaluronate ovd

Conditions: Bilateral Cataract; Unilateral Cataract

Summary: prospective, randomized, subject/evaluator-masked post market clinical study at up to 2 sites at gemini eye clinic in czech republic. randomization will be done by the eye surgeon. the purpose of this post market clinical trial is to compare the safety and efficacy of ophtesis bio 3% with a similar 3% sodium hyaluronate ovd in routine cataract surgery.

the purpose of this clinical study is to evaluate the performance of the ophtesis bio 3%. the primary endpoint is the rate of intraocular pressure (iop) spikes of 30 mmhg or greater at the 7-day postoperative visit. the secondary endpoint will be the rate of user acceptance evaluated using the surgeon questionnaire at the surgery day visit. other key endpoints will include iop and iop change from baseline at the 7-day postoperative visit, rate of inflammation measured using slip lamp at the 7-day postoperative visit, and rates of serious and/or device-related adverse events. number of subjects/eyes: up to 296 eyes will be enrolled to achieve approximately 148 operated eyes per group.

Eligibility criteria:
inclusion criteria: * cataract for which extraction and posterior intraocular lens (iol) implantation have been planned for one or both eyes * clear intraocular media, other than cataract * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) * recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject * use of systemic or ocular medications that may affect iop * known steroid responder * ocular hypertension of ≥ 20 mmhg, medically-controlled ocular hypertension (regardless of iop value), or glaucomatous changes in the optic nerve * patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes * concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial

Keywords: cataract eye surgery ovd ophtesis bio sodium hyaluronate
targeting cd19/cd20 dual-targeted cell in patients with relapsed/refractory b-cell non-hodgkin lymphoma

Conditions: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Summary: a phase i, open-label clinical study to evaluate the safety, tolerability, and efficacy of lucar-g39p, a dual-targeted cell preparation targeting cd19/cd20, in patients with relapsed/refractory b-cell non-hodgkin lymphoma

his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of lucar-g39p in the patient ≥ 18 years of age with relapsed or refractory b-cell non-hodgkin lymphoma. subjects who meet the eligibility criteria will receive a single dose of lucar-g39p injection. the study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. 2. aged 18-75 years (inclusive). 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. histologically confirmed b-cell non-hodgkin lymphoma that expresses at least one of cd19/cd20. 5. at least one evaluable tumor lesion according to lugano 2014 criteria. response to prior therapy is consistent with one of the following: 1. primary refractory. 2. relapsed or refractory after 2 or more lines of therapy. 3. for lbcl, 3b fl. t-inhl: * relapse within 12 months after first-line chemoimmunotherapy to achieve cr; * progression or relapse within 12 months after autologous hematopoietic stem cell transplantation; 7. life expectancy≥ 3 months 8. clinical laboratory values meet screening visit criteria exclusion criteria: subject eligible for this study must not meet any of the following criteria: 1. prior antitumor therapy with insufficient washout period ; 2. patients who received autologous car-t cell therapy (except cd19-targeted) or autologous gene therapy; 3. patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. patients who are positive for any index of hepatitis b surface antigen (hbsag), hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis c antibody (hcv-ab), hepatitis c virus ribonucleic acid (hcv rna), or human immunodeficiency virus antibody (hiv- ab). 6. known life-threatening allergies, hypersensitivity, or intolerance to lucar-g39p car-t cell or its excipients, including dmso. 7. pregnant or lactating women; -
exploratory subjective sleep study of a prototype nasal dilator

Conditions: Sleep Disorders; Congestion, Nasal

Summary: the purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.


Eligibility criteria:
inclusion criteria: * subjects with leptorrhine noses * subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

Keywords: trouble with sleep night time nasal congestion
low-dose hydroxychloroquine and bromhexine: a novel regimen for covid-19 prophylaxis in healthcare professionals

Conditions: Hydroxychloroquine; Antimalarials; Enzyme Inhibitors; Antirheumatic Agents

Summary: this study will investigate the security and efficacy of a daily low dose of hydroxychloroquine and bromhexine, in preventing the development of the disease from covid-19 in health care workers at a national institute of health in mexico city.

this study will combine two drugs (hydroxychloroquine and bromhexine) to see if hydroxychloroquine is better in combination with bromhexine in preventing the development of the disease from covid-19 in health care workers at a national institute of health in mexico city. hydroxychloroquine will be used in a low dose (200 mg every 24 hrs). bromhexine will be 8mg every 8 hrs. the study groups will be the following: 1) hcq 200mg/d + bhh placebo 2) hcq placebo plus bhh placebo

Eligibility criteria:
inclusion criteria * health personnel working at inr lgii or incmnsz who wish to participate in the study and sign the informed consent. * over 18 and under 60 years of age, both genders. * contacting with suspected or confirmed sars-cov-2 infection. * normal electrocardiogram. exclusion criteria * positive quantitative reverse transcriptase-polymerase chain reaction (qrt-pcr) test for sars-cov-2 at the time of inclusion. * panel of igg or igm antibodies positive for sars-cov-2 at the time of inclusion. * development of respiratory symptoms suspicious of sars-cov-2 infection during the first 7 days after treatment is initiated, confirmed by qrt-pcr and igg or igm antibodies postiver for sars-cov-2. * history of allergies to any hydroxychloroquine or bromhexine related compound or medication. * use of immunosuppressors for any reason. * history of bone marrow transplant. * known glucose-6-phosphate dehydrogenase deficiency. * chronic kidney disease or glomerular filtration \<20ml/min. * use of other drugs with reported pharmacological interactions (i.e., digitalis, flecainide, amiodarone, procainamide, or propafenone). * history of long qt syndrome. * electrocardiogram with qtc\>500 msec. * pregnant or breastfeeding personnel. * epilepsy. * known liver disease. * personnel who have received the covid-19 vaccine elimination criteria * personnel who decide to leave the study for any reason not related to adverse events. * personnel with incomplete information on the primary outcome (qrt-pcr for sars-cov-2). * personnel who are relocated to work in another institution. * personnel who do not wish to participate in the study

Keywords: sars-cov-2 covid-19 hydroxychloroquine bromhexine
extending veteran participation in the validation of the sci-qol/cat

Conditions: Spinal Cord Injuries

Summary: the field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool. the national institute of health has provided funding to develop a spinal cord injury-specific, quality of life survey tool in non-veterans with spinal cord injury called the spinal cord injury-quality of life (sci-qol). this quality of life survey asks questions regarding physical/medical, emotional, and social health as it relates to individuals with spinal cord injury. the purpose of this study is to include a veteran population in the making of the quality of life survey. each participant will be asked to complete a packet of quality of life questions. participants will be given the opportunity to take the survey a second time, either 7-14 days or 5-7 months after the first survey. taking the survey twice will allow the research team to test the reliability of the survey. comparing the sci-qol with other legacy measures will allow the investigators to test the validity of the survey. additionally, the investigators will be testing the sci-qol between veterans and non-veterans with sci to determine if there are differences in their self-reported quality of life. this study will be recruiting participants at the james j. peters veterans affairs medical center, bronx, new york and the james a. haley veterans affairs hospital, tampa, florida.


Eligibility criteria:
inclusion criteria: * male and female veterans with traumatic spinal cord injury * at least 18 years old * persons judged by their primary care doctor to be competent * able to read * fluent in english. exclusion criteria: * veterans with non-traumatic spinal cord injury ("non-traumatic" is defined as any injury from a chronic condition that resulted in decline of function due to the paralysis. these conditions include, but are not limited to: multiple sclerosis, arteriole-venous malformation, nerve impingement syndromes, congenital birth defects, or other) * diagnosis of a cognitive impairment (in the clinical chart) such that it limit the subject's ability to read, understand, and respond to statements about quality of life * not fluent in english.

Keywords: spinal cord injuries quality of life
evaluation of artificial intelligence models for diagnosis of anterior open bite malocclusion

Conditions: Artificial Intelligence; Open Bite

Summary: building artificial intelligence models for diagnosis of anterior open bite malocclusion

the study aims at creating artificial intelligence models, with the input being the pre-treatment photographs and radiographs of open bite patients that are routinely taken for diagnosis and treatment planning. the output of the ai model will be the type and phenotype of anterior open bite. the photographs and radiographs with highest quality will be arranged in certain standardized templates to facilitate the machine learning process.

Eligibility criteria:
inclusion criteria: * anterior open bite exclusion criteria: * craniofacial syndromes, previous orthodontic treatment, poor quality records
parents' occupation after diabetes onset

Conditions: Type 1 Diabetes

Summary: a cross-sectional multicenter study using a questionnaire assessing occupational and financial situation before and after the onset of type 1 diabetes was distributed to all families with a child diagnosed with type 1 diabetes before the age of 14 years in nine german pediatric diabetes centers.

this cross-sectional multicenter study was conducted between january and june 2018 during a three months period per center. the selected nine pediatric diabetes centers covered all regions of germany. the study participants were mothers, fathers, or other primary caregivers of children and adolescents diagnosed with type 1 diabetes before 14 years of age. during a regularly scheduled medical visit, in germany usually 4 per year, families were informed about the study procedure, its aims and anonymous data collection and analyses. the answered questionnaires were either collected in a closed box in each diabetes center or could be sent anonymously via a prepaid envelope to the study administration center.

Eligibility criteria:
inclusion criteria: * mothers, fathers or other primary caregivers of children and adolescents diagnosed with type 1 diabetes before 14 years of age * child's diabetes duration at least 12 months * child's age under 19 years exclusion criteria: * caregivers unability to understand german language sufficiently

Keywords: type 1 diabetes, parents, occupation, gender inequality
clinical evaluation of an experimental remineralization product

Conditions: White Spot Lesion

Summary: the study is designed as a split-mouth randomised controlled study. this means within the mouth of one patient one tooth with an initial lesion is treated and coated with the experimental remineralization product whereas another comparable tooth with an initial lesion is left untreated. patients are included upon meeting the inclusion criteria as defined for this clinical trial. in the test group, a remineralization of the incipient carious lesion is expected. the patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.


Eligibility criteria:
inclusion criteria: * at least two incipient carious lesions on the buccal or oral surface of a permanent tooth. neighbouring teeth should not be in two different groups. there is no maximum amount of lesions. * active caries lesion * patient at risk of caries * vital teeth exclusion criteria: * pregnancy * enamel detachment at the site of investigation * allergies (doremin) * chronic diseases

Keywords: white spot lesion